Posts Tagged ‘ paxil-heart-defects-newborn ’

Questions about Antidepressants and Pregnancy

January 14th, 2011. By AbiK

There’s a lot in the news about pregnancy and antidepressants (SSRI’s in particular—and especially Paxil, which has a Category D rating by the FDA). And we get a lot of comments and emails from readers who are either looking for information about SSRI drugs and pregnancy—or who share their stories about negative side effects they’ve experienced while taking antidepressants.

It’s a tough call—particularly when depression and pregnancy are not exactly mutually exclusive of each other. As any mom will tell you—even the ones who “just love being a mom!” and “always wanted to have at least 4 kids!”—you know who I mean—there are moments when you’re exhausted, down, emotionally drained. For many, it’s a circumstantial situation that, given a few hours, some diversions, or a good workout, tends to go away and resolve on its own. But not for everyone. And that’s where depression medication comes into play. Bottom line, it’s no accident that “Peanut Butter, Playdates & Prozac” became a popular read…

We publish a lot of information at LawyersandSettlements to help readers understand what’s going on with antidepressant lawsuits. But we also post background information as well—and for those of you who’ve written in requesting information about antidepressants and pregnancy, I’ve pulled some of our informative posts. Here they are:

Paxil Birth Defects: Baby Beware! A look at Paxil, pregnancy and depression

Antidepressant Guide: the Brands, the Generics & Who Makes Them List of antidepressant brand names and the names of their generic equivalents, and their manufacturers

Antidepressants: Know what they’re Winding you Up With Information about antidepressant drug classifications–the “umbrella” categories that antidepressant drugs fall into: SSRI, SNRI, NDRI, MAOI, and Tricyclics.

Having a Baby? Get to Know the FDA Drug Classifications Information about FDA pregnancy ratings for drugs. (Category A, Category B, Category C, Category D, and Category X—the system in which Paxil has been classified as Category D; and antidepressants like Effexor and Celexa are Category C. For those wondering, the Prozac pregnancy rating and the Zoloft pregnancy rating are both Category C at present as well).

Mom Alert: Would you want a 68% Higher Risk of Miscarriage? Study showing high rate of SSRI miscarriage risk—as well as SNRI and Tricyclic risk. Study looked at citalopram, fluoxetine, fluvoxa-mine, paroxetine, sertraline, ami-triptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, trimipramine, venlafaxine, serotonin modulators, monoamine oxidase inhibitors, tetracyclic piperazino-azepines, and dopamine and norepinephrine reuptake inhibitors.

Hope this info helps—but remember, please consult your physician for medical advice about your particular situation—only your doctor(s) can advise and treat you. If you need legal help…that’s another story…

Tags: Antidepressant, paxil, Paxil birth defects, paxil-heart-defects-newborn, Pregnancy, Pregnancy Cateogory, prozac-birth-defects-lung-heart, prozac-heart-birth-defect, SNRI, SSRI, ssri_birth_defects, zoloft-heart-birth-defect, zoloft-lung-heart-birth-defects
Posted in Drugs/Medical, Emerging Issues | 2 Comments »

2010: Annus Horribilis for GlaxoSmithKline?

December 20th, 2010. By Kristine B

Let’s face it, lots of drug companies face a variety of lawsuits and fines from the government. But 2010 might be a year that GlaxoSmithKline would wipe from its memory if it could—a sort of annus horribilis, if you will. Between the reported Paxil settlements, massive fines for illegal activity at its Puerto Rico plant and huge restrictions on its diabetes drug, Avandia, GSK appeared to be facing a TKO as we moved into 4Q’2010. So officials at GlaxoSmithKline could be forgiven if they toast the New Year and hope it’s better than the last 12 months…

Paxil Settlements

Earlier this year, various media outlets reported that GlaxoSmithKline agreed to settle certain lawsuits alleging Paxil caused birth defects. According to Bloomberg, the drug maker agreed to pay more than $1 billion to settle approximately 800 lawsuits.

Meanwhile, a separate lawsuit also alleging Paxil birth defects, saw the family of an infant who died less than two months after birth, settle with GlaxoSmithKline for an undisclosed amount. In yet a different lawsuit, the family of a boy born with heart defects was awarded $2.5 million by a jury, which found that GlaxoSmithKline officials “negligently failed to inform” the mother’s physician about the risk of birth defects.

Fines for the Glaxo Puerto Rico Plant

In October of this year, GlaxoSmithKline agreed to pay $750 million to settle allegations of wrongdoing at the company’s Puerto Rico plant, which is now closed. An investigation into the plant found that improper manufacturing procedures resulted in medications that could split apart or had improper amounts of the active ingredient. Officials alleged that GlaxoSmithKline knowingly manufactured, distributed and sold medications that did not meet FDA standards.

As part of the settlement, a whistleblower in the case received a whopping $96 million. So for her, 2010 might just have been a fantastic year.

Avandia

Also this year, GlaxoSmithKline learned that its diabetes drug, Avandia, would carry severe restrictions on who can take the medication. The decision came after an FDA advisory panel recommended that use of Avandia be restricted in light of serious side effects. Patients who are not currently on Avandia will have to try other diabetes medications before using Avandia and will have to show they have been made aware of Avandia side effects. Although some people consider it a victory that Avandia was not pulled entirely from the market, these restrictions will likely have an impact on Avandia profits.

Based on those three issues alone, 2010 might be a year that GlaxoSmithKline tries—ever so hard—to forget.

Tags: Avandia, avandia-heart-attack, GlaxoSmithKline, GSK, paxil, paxil-heart-defects-newborn
Posted in Drugs/Medical | No Comments »

Giddy with Glee: FDA Got One Right with SSRI Drug

October 18th, 2010. By AbiK

Or so it appears.

A little bomb just dropped in the form of a report out in the British Medical Journal (BMJ) regarding the antidepressant drug reboxetine. Reboxetine—brand name Edronax—is one of the drugs classified as a Selective Serotonin Reuptake Inhibitor, or SSRI, and it’s manufactured by Pfizer. According to the report, data from industry-sponsored (biased?) trials that have been published in peer-reviewed journals are misleading when it comes to reboxetine’s safety and efficacy.

How did this happen? Well, according to an article over at medscape.com, the BMJ reports that “74% of the data on patients who took part in the trials of reboxetine were not published because the findings were negative and that the data that were published about reboxetine overestimated its benefits and underestimated its harm.”

Huh?

I feel like I’m sitting in a management meeting—not at LawyersAndSettlements.com mind you—where we’ve just received the results of an employee feedback survey—that happen to suck—and we’re all trying to figure out how to save face and mitigate any fallout. What to do? LIE! Or, simply be selective in what information gets revealed…

So re: reboxetine, little bothersome details like the trial revealed that there was no significant difference in remission between reboxetine and a placebo, and that reboxetine was found to be inferior to other SSRIs such as fluoxetine (Prozac), paroxetine (Paxil) and citalopram (Celexa), just never hit the light of day. Until now.

But here is what makes me giddy with glee: reboxetine had been approved for marketing in the UK, Germany and “other European countries” according to the medscape.com article….”but did not win approval in the United States.”

Looks like the FDA got one right! Can it be so…?

Tags: Celexa, Edronax, FDA, paxil, paxil-heart-defects-newborn, Prozac, Reboxetine, SSRI
Posted in Drugs/Medical | 2 Comments »

Mom Alert: Would you want a 68% Higher Risk of Miscarriage?

June 2nd, 2010. By LucyC

A new study out yesterday—June 1, 2010—has revealed a higher rate of miscarriages in women who were taking antidepressants during pregnancy. How much higher? Sixty-eight percent—yes —that’s 68%—higher. Frankly, that is nothing short of shocking.

Published in the Canadian Medical Association Journal, the study was done in Canada through the University of Montreal. FYI—This was no small study either—the investigators used data from 5,124 women who are part of a large, population-based study of pregnant women who had clinically verified miscarriages, and a large sample of women from the same registry who did not have a miscarriage. Among the women who miscarried, 284 or 5.5 percent, had taken antidepressants during their pregnancy.

In fact the findings are so robust that the physicians who did the study are suggesting that this is a class effect—in other words the effect could be attributed to all selective serotonin reuptake inhibitors—or SSRIs. Here’s what’s being reported in the press:

“These results, which suggest an overall class effect of selective serotonin reuptake inhibitors, are highly robust given the large number of users studied,” the study’s senior author, Dr. Anick Berard, said in a statement. (UPI.com)

The antidepressants that showed a particular association with miscarriage in the study were paroxetine (trade names: Seroxat and Paxil) and venlafaxine (trade names: Effexor, Efexor, Alventa, Argofan, Trevilor). The investigators also found that the risk of miscarriage doubled with a combination of different antidepressants.

Just for the record, the antidepressants “investigated” in the University of Montreal study are serotonin reuptake inhibitors (citalopram, fluoxetine, fluvoxa-mine, paroxetine and sertraline); tricyclic antidepressants (ami-triptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, trimipramine), Read the rest of this entry »

Tags: Celexa, Cymbalta, Effexor, Lexapro, paxil, paxil-heart-defects-newborn, Prozac, SNRI, SSRI, Zoloft
Posted in Drugs/Medical | No Comments »

Antidepressant Guide: the Brands, the Generics & Who Makes Them

May 6th, 2010. By Kristine B

These days, there are many drugs to keep track of. It’s not just the brand name drug anymore; patients could be taking a generic equivalent. So, this week, Pleading Ignorance looks at the SSRIs and SNRIs to give you the brand name, manufacturer, generic version and the generic’s manufacturer. Consider it your one-stop cheat sheet on some of the more commonly prescribed antidepressants.

Brand name	Ingredient	Made By	Generic	Made By
Celexa (SSRI)	citalopram hydrobromide	Forest Laboratories	citalopram	Eon Labs, Inc., Aurobindo Pharma Limited, Purepac Pharmaceutical Co., Dr. Reddy’s Laboratories Limited, Corepharma LLC
Lexapro (SSRI)	escitalopram oxalate	Forest Laboratories	escitalopram	Alphrapharm
Paxil/Seroxat    (SSRI)	paroxetine hydrochloride	GlaxoSmithKline	paroxetine	Apotex, Alphapharm, Teva, Aurobindo Pharma, Zydus Pharms USA, Caraco
Prozac (SSRI)	fluoxetine hydrochloride	Eli Lilly and Company	fluoxetine	ESI Lederle (tentative approval)
Symbyax (SSRI)	olanzapine and fluoxetine hydrochloride	Eli Lilly and Company	olanzapine/ fluoxetine	Teva Pharms (tentative approval, July 17, 2007)
Zoloft (SSRI)	sertraline hydrochloride	Pfizer Pharmaceuticals	sertraline	Dr Reddy’s Labs Ltd, Teva, Genpharm, Aurobindo Pharma, Sandoz and many others
Zyprexa (atypical antipsychotic)	olanzapine	Eli Lilly and Company	olanzapine	All tentative approval: Dr. Reddy’s Labs Inc, Teva Pharms, Mylan PHarma, Sandoz, Barr Pharms, Roxane
Cymbalta (SNRI)	duloxetine hydrochloride	Eli Lilly and Company	duloxetine	No generic so far as I can tell
Effexor (SNRI)	venlafaxine	Wyeth	venlafaxine hydrochloride	Aurobindo, Mylan, Teva, Dr Reddy’s Labs Ltd, Caraco and others

The information in the chart above was found at either drugs@fda, or on the individual drug manufacturer’s website. As far as I can tell, this information is correct as of the date it was written—and it is not intended to replace the information you might receive from your doctor or medical practitioner (hey, have to say it, we’re a legal site). Talk to your doctor or pharmicist for medical advice.

Tags: Antidepressants, Celexa, Cymbalta, Effexor, Lexapro, paxil, paxil-heart-defects-newborn, Pleading Ignorance, Prozac, SSRI, Symbyax, Zoloft, Zyprexa
Posted in Drugs/Medical, Emerging Issues | 1 Comment »